Covidien Plc (COV) in its update on voluntary recall of BIS Bilateral Sensors said to date, there have been no reports of patient injury related to the recalled products.
On November 8, 2011, the company initiated a voluntary recall of certain lots of its BIS Bilateral Sensors, due to a modification which inadvertently reversed the reference and left eye electrode. Covidien noted that this modification could potentially cause a change in the performance of BIS monitoring systems when these sensors are used, resulting in the inaccurate calculation and presentation of processed EEG information for Bispectral Index, or BIS, Density Spectral Array and Asymmetry values.
by RTT Staff Writer
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